Boston Scientific wins FCA whistleblower suit over Cognis CRT-Ds, Teligen ICDs

Boston Scientific (NYSE:BSX) has prevailed in dismissing a whistleblower suit alleging its sales of the Cognis cardiac resynchronization therapy defibrillators and Teligen implantable cardioverter defibrillators between 2008 and 2009 violated various false claims acts, according to court documents released late last week. In the suit, Boston Scientific was accused of defrauding the FDA by not reporting alleged defects in the devices which caused insecure connections between the leads and headers they attached to. The complaint alleged that Boston Scientific was made aware of the issue after launching the devices in Europe, and upon US launch it engaged in a strategy of minimizing medical device reports to the FDA covering the defects. When the company released revised versions of the devices, it called the revisions modifications and not corrections, according to the complaint. Boston Scientific then issued a recall for the original devices in mid 2009. The United States District Court for the District of Minnesota dismissed the allegations, referencing that while allegations were made that the company defrauded the FDA and violated the False Claims Act, there were no specific references to actions or statements taken to defraud the Agency. “To satisfy the rule, “the complaint must plead such facts as the time, place, and content of the defendant’s false representations, as well as the details of the defendant’s fraudulent acts, including when the...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Assist Devices Legal News Boston Scientific Source Type: news

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AbstractThe single right ventricle (RV) in hypoplastic left heart syndrome (HLHS) often develops systolic dysfunction with time and this affects prognosis. Mechanical dyssynchrony has been reported in HLHS but has not consistently correlated with systolic function or electrical dyssynchrony. The aims of this study were to assess the relationship between RV mechanical dyssynchrony, RV systolic function, and QRS duration on surface electrocardiography. We hypothesized that surface QRS duration would not be an adequate indicator of mechanical dyssynchrony compared with dyssynchrony parameters. Retrospective analysis of echoca...
Source: Mammalian Genome - Category: Genetics & Stem Cells Source Type: research
Pacing and Clinical Electrophysiology, Volume 0, Issue ja, -Not available-.
Source: Pacing and Clinical Electrophysiology : PACE - Category: Cardiology Authors: Tags: EDITORIAL ‐INVITED Source Type: research
Cardiac resynchronization therapy (CRT) improves quality of life and survival in patients with heart failure, but it has not been rigorously investigated in LVAD patients. Furthermore, the effects of different pacing strategies on hemodynamics in LVAD recipients is unknown.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: 91 Source Type: research
We present the full study cohort of the first prospective study evaluating outcomes with right ventricular (RV) vs biventricular (BiV) pacing in LVAD patients.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: 90 Source Type: research
Exercise-induced left bundle branch block (LBBB) is rarely observed in exercise testing, and usually implies a worse prognosis. Cardiac resynchronization therapy (CRT) is well validated in patients with heart failure with reduced ejection fraction (HFrEF) and LBBB. Although the indications of CRT do not include exercise-induced LBBB, the functional impairment secondary to dynamic electromechanical dyssynchrony could potentially be improved with CRT.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: 71 Source Type: research
Cardiac resynchronization therapy (CRT) has been shown to shorten QRS duration (QRSd) and improve ejection fraction (EF) in adults with congenital heart disease (ACHD) and children with heart failure with reduced ejection fraction (HFrEF). It is not known whether CRT confers a survival benefit. We sought to determine whether CRT is associated with longer transplant-free survival after adjusting for patient factors.
Source: The Journal of Heart and Lung Transplantation - Category: Transplant Surgery Authors: Tags: 478 Source Type: research
The FDA has given BIOTRONIK approval to introduce the company’s Acticor and Rivacor lines of high-voltage cardiac rhythm implants. They’re designed to treat tachycardia (likely supraventricular tachycardia (SVT) and have been made to be s...
Source: Medgadget - Category: Medical Devices Authors: Tags: Cardiology Source Type: blogs
ABSTRACTBackground and aimsPatients with moderate ‐to‐severe chronic kidney disease (CKD) are underepresented in clinical trials of cardiac resynchronization therapy (CRT)‐defibrillation or CRT‐pacing (CRT‐P). We sought to determine whether outcomes after CRT‐D are better than after CRT‐P over a wide spectrum of CKD.Methods and resultsClinical events were quantified in relation to pre ‐implant estimated glomerular filtration rate (eGFR) after CRT‐D (n = 410 [39.2%]) or CRT‐P (n = 636 [60.8%]) implantation. Over a follow‐up period of 3.7 years (median, interquartile range: 2.1‐5.7), the eGFR
Source: Pacing and Clinical Electrophysiology : PACE - Category: Cardiology Authors: Tags: DEVICES Source Type: research
Cardiac resynchronization therapy (CRT) improves mortality, morbidity and quality of life in selected heart failure patients with severe left ventricular ejection fraction impairment. However, between 20% and 40% of device recipients do not benefit clinically from CRT. Indeed, some anatomical and technical difficulties are related to the coronary venous implantation site via the coronary sinus (CS). Additionally, electrical constraints have been described and CS does not always correspond to the optimal LV lead position.
Source: Heart Rhythm - Category: Cardiology Authors: Source Type: research
ConclusionDaily multiparameter telemonitoring has a potential to reduce clinical endpoints in patients with chronic systolic heart failure both in ICD and CRT-D subgroups. The absolute benefit seems to be higher in higher-risk populations with worse prognosis.
Source: Clinical Research in Cardiology - Category: Cardiology Source Type: research
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